Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Seizures

Lacosamide can be initiated with either oral or intravenous administration.

Initial dose: 50 mg twice daily (100 mg per day). Lacosamide can be increased at weekly intervals by 100 mg/day given as two divided doses up to the recommended maintenance dose of 200 to 400 mg/day, based on individual patient response and tolerability. In clinical trials, the 600 mg daily dose was not more effective than the 400 mg daily dose, and was associated with a substantially higher rate of adverse reactions.

Oral lacosamide may be taken with or without food.

Usual Pediatric Dose for Seizures

17 years of age and older:

Lacosamide can be initiated with either oral or intravenous administration.

Initial dose: 50 mg twice daily (100 mg per day). Lacosamide can be increased at weekly intervals by 100 mg/day given as two divided doses up to the recommended maintenance dose of 200 to 400 mg/day, based on individual patient response and tolerability. In clinical trials, the 600 mg daily dose was not more effective than the 400 mg daily dose, and was associated with a substantially higher rate of adverse reactions.

Oral lacosamide may be taken with or without food.

Renal Dose Adjustments

No dose adjustment is considered necessary in mildly and moderately renal impaired subjects. A maximum dose of 300 mg/day is recommended for patients with severe renal impairment (CrCl less than or equal to 30 mL/min) and in patients with end-stage renal disease.

In all renal impaired patients, the dose titration should be performed with caution.

Liver Dose Adjustments

Lacosamide use is not recommended in patients with severe hepatic impairment.

A maximum dose of 300 mg/day is recommended for patients with mild or moderate hepatic impairment. The dose titration should be performed with caution in patients with hepatic impairment.

Dose Adjustments

When switching from oral to intravenous lacosamide, the initial total daily intravenous dosage of lacosamide should be equivalent to the total daily dosage and frequency of oral lacosamide and should be infused intravenously over a period of 30 to 60 minutes. There is experience with twice daily intravenous infusion for up to 5 days.

At the end of the intravenous treatment period, the patient may be switched to lacosamide oral administration at the equivalent daily dosage and frequency of the intravenous administration.

Patients treated with lacosamide who have severe hepatic or renal impairment and who are also taking strong inhibitors of CYP450 3A4 and CYP450 2C9 may have a significant increase in exposure to lacosamide. Dose reduction may be necessary in such patients.

Precautions

Safety and effectiveness have not been established in pediatric patients under the age of 17 years.

Dialysis

Lacosamide is effectively removed from plasma by hemodialysis. Following a 4 hour hemodialysis treatment, the AUC of lacosamide is reduced by approximately 50%. Therefore dosage supplementation of up to 50% following hemodialysis should be considered.

Other Comments

Lacosamide injection can be administered intravenously without further dilution or may be mixed with diluents.

When using lacosamide oral solution, it is recommended that a calibrated measuring device be obtained
and used. A household teaspoon or tablespoon is not an adequate measuring device. Healthcare
providers should recommend a device that can measure and deliver the prescribed dose accurately and provide instructions for measuring the dosage.

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